Presented by
Management Forum

Variations to Marketing Authorisations

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

26-27 Apr 2022 + 1 more date

Enrol now

  • Format: Live online
  • CPD: 12 hours for your records
  • Certificate of completion

Course overview

It is a key post-marketing responsibility of the marketing authorisation holder (MAH) to keep dossiers up to date, and changes must be submitted as variations to the appropriate regulatory authority.

This interactive event will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures. The course will cover the latest variation regulations and offer guidance from an industry expert on how to optimise your regulatory procedures to help achieve faster approval. The programme will include filing tips and strategies with information and advice on creating a global dossier and implementation periods.

Practical sessions throughout the two days will provide an opportunity to discuss different scenarios and strategies with other participants.

Benefits of attending:

  • Gain an overview of the EU system for variations
  • Assess how pharma companies are working in this evolving regulatory environment
  • Profit from practical advice on the preparation and submission of variation applications
  • Understand the impact of Module 3 on your variations dossier
  • Discuss filing tips and strategies to help achieve faster approval

Who should attend?

This course will be particularly relevant for those working in registration and regulatory affairs. It will also be of interest to anyone with an involvement in the variations process including QA, clinical safety and pharmacovigilance personnel.

Enrol now

The Variations to Marketing Authorisations course will cover:

Basis of EU Regulations 1234/2008 and 712/2012

  • Classification in accordance with the legislation
  • Understand the differences between type lA, type IB and type ll variations
  • Clarify foreseen and unforeseen variations

Special topics in variations

  • Handling active ingredient master files as variations
  • Submission of new clinical data

Practical session: Analysing and classifying the different changes

Grouping and work-sharing

  • Understanding when grouping is appropriate
  • Clarifying what types of variations may be grouped
  • Guidance on assembling a grouped submission
  • Understanding when work-sharing is appropriate

Understanding Module 3

  • The dossier impact on variations
  • QbD
  • CQA pyramids

Practical session: Understanding reviewers

Filing strategy

  • Creating a global dossier (gold/silver/ bronze versions)
  • Understanding implementation and grace periods
  • Fixed and rolling implementation strategy

Practical session: Plan the timelines/project management of a variation submission

Other procedures

  • Article 5
  • Urgent safety restrictions
  • Understanding when to use extension applications

Submission planning

  • Identify and understand strategic considerations

Data requirements for type II variations

  • Learn how to identify and support a type II change

Practical session: Data requirements for more complex changes

Variations through national procedures and differences from centralised procedure

  • Understand the procedures
  • Languages and translations
  • Explore the linguistic review process

Mutual recognition and decentralised procedures for variations

  • Understand the procedures and responsibilities of the MAH, RMS and CMS
  • Learn how to efficiently plan for and run an MR variation procedure

Practical session: A variation to an example MRP authorised product including planning timelines and impact of referrals

Advanced compliance

  • Creating your own compliance requirements
  • SUPAC guidance

Enrol now

Marloes van der Geer

Marloes van der Geer works as senior regulatory affairs scientist at Qdossier. Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Marloes has been actively involved in several industry associations like EFPIA and IFPMA. Also, she contributed to the ongoing IMI PREFER project in Europe, focused on the generation and use of patient preference data. In 2019, Marloes joined Qdossier. Marloes’ areas of expertise are: eCTD, lean authoring, publishing, biopharmaceuticals (incl. biosimilars), clinical development, regulatory convergence & harmonization and facilitated registration pathways (incl. orphan drugs), local RA activities (e.g. product information management).

More details

Book Variations to Marketing Authorisations Live online training

26-27 Apr 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11613

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 22 Mar

In your basket 

13-14 Oct 2022

Live online

00:00-00:00 UK (London) (UTC+01)
01:00-01:00 Paris (UTC+02)
19:00-19:00 New York (UTC-04)
Course code 11721

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 08 Sep

In your basket 

Reviews of IPI's Variations to Marketing Authorisations training course


Excellent webinar! [Speaker is] engaging and friendly.

Apr 13 2021

Abhijit Nair
Regulatory Affairs Officer, Consilient health

Apr 13 2021

It was very interesting and informative.

Dubravka Božičević
Senior Advisor for Validation of Applications, Cratian Agency for medicinal products and medical devices - HALMED

Oct 8 2020

Excellent, clear and interactive

Mohit Pandey
Morningside Healthcare Limited

Oct 8 2020

Andrew is a good speaker and managed to keep our attention during these two days despite the fact that it was a webinar.

Chloë Braud
International Regulatory Affairs Pharmacist, Guerbet

UK

  • 3M Healthcare Ltd
  • Abbott Laboratories Ltd
  • Allergan UK Limited
  • Allergy Therapeutics Ltd
  • Alliance Pharmaceuticals Ltd
  • Almac Group
  • Archimedes Pharma Ltd
  • Archimedes Pharma UK Limited
  • Avon Automotive plc
  • Bayer Healthcare
  • BOC Ltd (part of the Linde Group)
  • Boehringer Ingelheim Ltd
  • Bristows LLP
  • Britannia Pharmaceuticals Ltd
  • Chemidex Pharma Ltd
  • Chiesi Limited
  • Co-Operative Pharmacy
  • Consilient health
  • Cross Vetpharm Group UK LTD
  • Cyton Biosciences Ltd
  • Dechra Ltd
  • E.C. De Witt & Company Limited
  • Eli Lilly & Co Ltd
  • Fresenius Kabi Ltd
  • Fresenius Kabi UK Ltd
  • Galderma (UK) Limited
  • Galen Ltd
  • Gilead Sciences International Ltd
  • GlaxoSmithKline
  • Ipsen Biopharm Ltd
  • Janssen-Cilag Ltd
  • JensonR+ Ltd
  • Karib Kemi Pharm Ltd
  • Lundbeck Limited
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Mentholatum Co Ltd
  • Milpharm Ltd/Aurobindo Pharma Limited
  • Morningside Healthcare Limited
  • Mylan
  • NAPP PHARMACEUTICALS
  • Novartis Pharmaceuticals UK Ltd
  • Pierre Fabre Ltd
  • Procter & Gamble Technical Centres Ltd
  • Ranbaxy Laboratories Ltd
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Roche Products Ltd
  • Rosemont Pharmaceuticals Limited
  • S A Consultancy Ltd
  • Sanofi Pasteur MSD Ltd
  • Shire Pharmaceutical Ltd
  • SHORE LTD
  • Sinclair IS Pharmaceuticals Ltd
  • Teva Pharmaceuticals Europe B.V.
  • Teva UK Ltd
  • Torbay Pharmaceuticals
  • UCB Celltech
  • Waymade Plc
  • Winthrop Pharmaceuticals UK Ltd
  • Wrafton Laboratories Ltd, t/a Perrigo

Belgium

  • GRUNENTHAL NV
  • Janssen Pharmaceutica NV
  • PHARA Plus Life Science Services BVBA
  • SCHERING-PLOUGH LABO NV

France

  • Galderma International
  • Guerbet
  • Sanofi Pasteur MSD

Netherlands

  • Abbott Healthcare Products BV
  • Intervet Nederland bv
  • Leyden Delta bv

Switzerland

  • Novartis International AG
  • Novartis Vaccines & Diagnostics AG
  • ObsEva

Croatia

  • Cratian Agency for medicinal products and medical devices - HALMED
  • Novartis Hrvatska doo

Czech Republic

  • Zentiva Group AS
  • Zentiva ks

Ireland

  • Irish Patents Office
  • Labopharm Europe Ltd

Israel

  • Blau Pharmaceutical Services
  • Perrigo Israel Pharmaceuticals Ltd

Austria

  • EVER Valinject GmbH

Denmark

  • Atnahs Pharma Nordics

Germany

  • Life Molecular Imaging

Malta

  • APL Swift Services (Malta) Ltd

Spain

  • Casen Recordati SL

Sweden

  • Fresenius Kabi AB

Enrol now

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy